Cultural Change in the Pharmaceutical Industry

Compliance as a business standard with EHS

The pharmaceutical industry is experiencing a period of heightened regulatory scrutiny, both in the United States and globally. This scrutiny is occurring in a number of areas, including compliance with regulations issues by the Medial & Healthcare Products Regulatory Agency (MHRA), the FDA, the Health Insurance Portability and Accountability Act (HIPAA) and others.

The heightened attention comes at a time when the average cost of developing one new medicine is about $500 million and it takes 12 to 15 years for it to reach the market. In this environment, manufacturers need every advantage they can generate in order to build efficient supply chain and profitable production practices that are within the boundaries of waste disposal, risk management and other regulatory mandates.

Build Compliance and Performance at the Same Time

To achieve this balance, leading pharmaceutical companies are moving beyond the Crisis Management approach to regulatory compliance that has been rather common in the industry and investing in the technologies and infrastructure necessary to achieve and demonstrate compliance with current and future regulatory requirements. They are choosing solutions that help them implement strategic plans that build compliance into the way they do business.

ESS, the leading provider of Operational Risk Management software and services for EHS and Crisis Management, helps clients in the pharmaceutical industry assure compliance and use their compliance data to identify performance-enhancing metrics that contribute to operational excellence and stakeholder value. The software helps them find new ways to create value and maintain regulatory compliance now, and in the future.